Experience

OncoBay Clinical
• United States
• Research Services
• 1 - 100 Employee
• Executive Medical Director

  • Jul 2022 - Present

Shasqi
• United States
• Biotechnology Research
• 1 - 100 Employee
• Executive Medical Director

  • Nov 2021 - Mar 2022

Prelude Therapeutics Incorporated
• Executive Director Clinical Science

  • Feb 2021 - Nov 2021


Merck

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Clinical Scientist (Medical Monitor)

  • Nov 2019 - Feb 2021

  Scientific lead on Clinical Trial Team (CTT). Clinical point of contact for scientific issues, questions, clarifications, for internal and external stakeholders (e.g. IRB, sites) Responsible for trial design and endpoint development in collaboration with Clinical Director.Leads the Medical Monitoring (MM) team in performing MM activities, including development of the Medical Monitoring Plan (MMP) and review of SAE reports. Sets up/supports SAC, DMC, adjudication committees. Protocols/amendments – collaborates with medical writer (MW), participates in governance committee review. Authors protocol clarification letters. Contributor to study specific documents (e.g., SMP). Reviews/updates informed consent. Provides scientific input to Study Manager (SM) for data management activities (e.g., EDC, DRP, CRFs). Monitors data issues requiring clinical input. Monitors central lab reports and other external data for safety and critical values. Prepares scientific slides, attends and presents protocol information at Investigator Meeting. Reviews specs, initiates allocation (randomization) request form and approval schedule in allocation schedule generation system. Coordinates planning of lab, bio specimens and imaging specifications. Co- authors newsletters with Study Manager. Participates in Database lock activities. Collaboratively plans CSRs, CTDs/WMAs with medical writing. Supports publications / presentations as needed. Reconciles and review all protocol deviation classifications in SPECTRUM.Assesses and prepares protocol deviation list for CSR. Collaborates with medical writing to develop trial results communication for investigators. Provides scientific assessment for Operational Reviews. Supports SM/MW activities as needed to achieve CTT deliverables. Provides clinical specifications to SM to support interactions with external vendors (e.g., IVRS, ePRO). Mentors other Clinical Scientists.  Therapeutic Area: Oncology Show less



BD

• United States
• Architecture and Planning

• Senior Clinical Project Manager

  • Apr 2019 - Nov 2019

  Worked without appreciable supervision and direction, prepared and/or reviewed study-related or essential study start-up documents as they relate to the assigned clinical trials (e.g., Clinical Protocols, Informed Con-sent forms, Investigator Brochures, Medical Monitoring Plan, Pharmacy Manual, Monitoring Plan, Laboratory Manual, Patient Diary, Clinical Site Procedures Manual, Case Report Form (CRFs), CRF Completion Guidelines and other relevant study plans and charters). Collaborated with Medical Directors and supported pharmacovigilance regarding safety and medical issues. Reviewed medical data as part of medical monitoring including labs, patient profiles, CRF data and eligibility, enrollment and protocol deviations. Conducted medical data review and generated data queries in collaboration with data management. Mentored other Clinical Project Managers. Lead and contributed to continuous improvement activities/initiatives. Managed relationships with sites/PIs. other study related vendors, including CRO’s. Implemented intermediate knowledge, of established project management standards used to develop and maintain integrated project plans (scope/work packages, time/schedule, cost /material and human resource, quality, communication/escalation, risk, value) and organizes /facilitates meetings and discussions as needed. Defined, tracked and reported schedule attributes such as durations, interdependencies, milestones, critical path and other key deliverables including efficiency and effectiveness of plans and staff. Created aggressive but achievable resource and budget forecasts and timelines. Interacted with both Internal and External contacts, providing direction to the GCD cross functional team members and vendors regarding the technical, protocol-specific and operational aspects of assigned studies.  Therapeutic Area: Oncology Show less



Astellas Pharma US

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Sr Clinical Study Manager

  • Dec 2016 - Mar 2019

  § Manage and lead the day-to-day operations of assigned US and Global studies to ensure completion per established project team goals and objectives in compliance with applicable GCP/ICH guidelines and other regulatory requirements. § Manage and lead cross-functional study teams, including vendors. § Responsible for accurate and up-to-date study information within CTMS and other relevant tracking systems and providing regular updates; proactively identifies and resolve issues that arise during study conduct; manage escalation of study-related issues. § Lead development of budgets and timelines for assigned studies. Ensure accurate forecasting, tracking, timely review and escalation of variances within established processes. § Lead development of study plans and system set-up; participate in preparation and ensure operational excellence of protocol, CRF, CSR and other key study team documents. § Participate in process improvement and quality-related initiatives associated with study execution and deliverables; participate in establishment of best-in-class processes and standards for study conduct. § Use appropriate systems and standard processes to ensure quality and consistency. § Determine requirements and scope; lead selection activities and effectively manage. Vendors. § Lead feasibility assessment and selection of countries and sites for study conduct. § Oversee the timely data cleaning, clinical aspects of data analysis and the availability of top line results. § Ensure set-up and implementation of effective site monitor training; coordinate operational and therapeutic area training for internal and external study team members. § Accountable for effective training of study team, study sites and vendors for assigned clinical studies. § Responsible for the preparation and management of budgets, timelines and resources for assigned clinical studies of up to $100M. Show less



Takeda

• Biotechnology
• 1 - 100 Employee

• Research Manager Medical Affairs

  • Apr 2015 - Jul 2016

  • Managed all aspects of the US External Research program including Investigator Initiated and Sponsored Research (IISR) studies for multiple therapeutic areas and product programs. Managed TA and product level study budgets and communicate study activities to internal stakeholders. • Oversight and managed the activities of USMA research project managers, including the initiation, tracking, completion, and reporting of studies. • Responsible for the conduct of IISR studies within assigned TA in accordance with all applicable internal legal and compliance policies as well as external regional and country specific regulatory guidelines. • Served as the US External Research therapeutic area lead for interfacing with internal stakeholders (e.g. GMA Region and LOC medical leads, TA Medical Heads, alliance partners, etc) and external investigators to develop and execute USMA research plans and budgets. • Assisted with the development of the annual USMA research strategy for assigned therapeutic area in collaboration with USMA Therapeutic Area Medical Directors and oversee allocation of the budget. • Oversight of receipt and processing of study submissions by Medical Affairs staff. Reviewed and approved research committee materials, • Chaired and assisted regions with the conduct of cross-functional TA research committee meetings. • Coordinated the capture, archiving and reporting of appropriate study level information (including patient safety information) from USMA IISR clinical trials in assigned TA. Ensured coordination with Pharmacovigilance and Regulatory Affairs to respond to external audits and requests from external regulatory bodies. • Oversight of the conduct fair-market value (FMV) assessments. • Collected and reported US External Research process metrics, key accomplishments, study status, and financial projections for assigned therapeutic area • Managed, directed, coached, and developed individual Project Managers as assigned. Show less



Abbott

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Associate

  • Jan 2011 - Apr 2015

  • Lead project manager on Investigator Initiated Clinical Trials within Abbott’s Internal Specimen Study Collection program. • Cross-functional responsibilities with Medical and Scientific Affairs IIS (Investigator Initiated Studies) process improvement program. • Responsible for clinical research monitoring activities required for design validation studies, including specimen procurement, for in vitro diagnostic products. • Assisted senior staff and interacted with R&D teams, Statistical Support department, and Medical Affairs in planning study and developing study conduct. • Lead CRA (as designated by projects) responsible in writing protocols, designing case report forms (CRFs), Contract Research Organization (CRO) selection and management, selection and training of investigator sites, planning and running study meetings, evaluation, selection and training of new study investigators to ensure compliance to protocol and ICH/GCP guidelines • Performed Pre-Study activities including qualification monitoring visit to site and securing essential documents. • Propose and negotiate budgets for clinical studies. Initiate payments to clinical sites. •Conduct Initiation, Interim and Close-Out monitoring visits. Write appropriate site visit trip reports. • Arrange for shipment of instruments, reagents, and supplies needed to conduct diagnostic product studies and specimen procurement studies. • Review all study documents and data generated at the clinical sites. Ensure that all CRFs are complete. Query site as needed. • Maintain accurate and timely correspondence and communication with the clinical sites. • Maintain master study files in an audit ready state. Participate in audit activities and responses. • Present study progress reports to management. • Support the preparation of clinical sections of regulatory submissions. • Maintain and acquire knowledge of regulations and standards affecting IVDs. Show less



NorthShore University HealthSystem

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Database Manager (Clinical Trials)

  • Sep 2007 - Sep 2010

  • Managed NIH and pharmaceutically sponsored clinical research studies from start up to close out in the Department of Neurology. • Ensured study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP and ICH guidelines. Assisted in patient recruitment. • Screened study patients and coordinated all study activities as required by the study protocol. • Effectively maintained both study drug and device accountability as well as documented and reported all AE’s and SAE’s to sponsor and the IRB. Functioned as regulatory coordinator. • Ensured accurate data collection and entry to CRF’s. • Managed research databases and prepared reports as required. Managed and tracked research funds. Worked side by side with The ENH Research Institute regarding any research related budget/contract activities. • Supervised and mentored graduate students, research assistants and coordinators. • Developed, wrote and managed investigator initiated study protocols. Show less



Rosalind Franklin University

• United States
• Hospitals and Health Care

• Clinical Research Manager

  • Jun 2006 - Sep 2007

  • Managed NIH and pharmaceutically sponsored multidisciplinary clinical research studies from start up to closeout. • Developed, wrote and managed investigator initiated study protocols. • Ensured study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP and ICH guidelines. Assisted in patient recruitment. • Screened study patients and coordinated all study activities as required by the study protocol. • Effectively maintained both study drug and device accountability as well as documented and reported all AE’s and SAE’s to sponsor and the IRB. Functioned as regulatory coordinator. • Ensured accurate data collection and entry to CRF’s. • Managed research databases and prepared reports as required. Managed and tracked research funds. Worked side by side with The Office of Sponsored Research regarding any research related budget activities. • Supervised and mentored graduate students, research assistants and coordinators. • Presented lectures in clinical research to graduate students in the College of Biomedical Sciences. Show less



Rush University Medical Center

• United States
• Hospitals and Health Care
• 700 & Above Employee

• Clinical Research Coordinator

  • Sep 2003 - May 2006

  • Primarily responsible for managing numerous NIH and pharmaceutically sponsored clinical research studies from start up to close out in the Department of Medicine, Section of Rheumatology. • Ensured study adherence to all regulatory matters and sponsor requirements according to FDA regulations, GCP and ICH guidelines. Assisted in patient recruitment. • Screened study patients and coordinated all study activities as required by the study protocol. Effectively maintained both study drug and device accountability as well as documented and reported all AE’s and SAE’s to sponsor and the IRB. • Ensured accurate data collection and entry to CRF’s. Managed research databases and prepared reports as required. Functioned as clinical back up and resource for both clinical and non-clinical staff. Show less